Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess comparative bioavailability and effect of food on a prototype fixed-dose combination (FDC) of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in healthy subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDC Fasting | Experimental | Day 1, Day 7, Day 13 |
|
| FDC Fed | Experimental | Day 1, Day 7, Day 13 |
|
| Reference Fasting | Experimental | Day 1, Day 7, Day 13 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fasting conditions | Drug | A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of FDC compared to reference:(Cmax) | Maximum plasma concentration (Cmax) | Day 1, Day 7, Day 13 |
| Pharmacokinetics (PK) of FDC compared to reference:(AUC) | Area under the plasma concentration-time curve (AUC) | Day 1, Day 7, Day 13 |
| Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(Cmax) | Maximum plasma concentration (Cmax) | Day 1, Day 7, Day 13 |
| Food effect of Fixed Dose Combination of Bemnifosbuvir (BEM)/Ruzasvir (RZR):(AUC) | Area under the plasma concentration-time curve (AUC) | Day 1, Day 7, Day 13 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atea Study Site | Cypress | California | 90630 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bemnifosbuvir (BEM)/Ruzasvir (RZR) FDC under fed conditions | Drug | A Fixed-Dose Combination of Bemnifosbuvir (BEM) and Ruzasvir (RZR) |
|
| Bemnifosbuvir (BEM) and Ruzasvir (RZR) as reference formulation under fasting conditions | Drug | Bemnifosbuvir (BEM) and Ruzasvir (RZR) as separate formulations |
|
| ID | Term |
|---|---|
| C000621654 | ruzasvir |
Not provided
Not provided
Not provided